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CancerNCT05829824

Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

A study testing CareConnect, AutoReach and Biospecimen samples in people with Cancer and Tobacco Dependence, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Tobacco Dependence, Tobacco Use Cessation
What is being tested?
CareConnect, AutoReach and Biospecimen samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
27 Nov 2023to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years and older.
  • Able to understand study procedures and to comply with them for the entire length of the study.
  • Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
  • English, Spanish, Cantonese, or Mandarin speaking.
  • Self-reported current use of tobacco, including e-cigarette on EHR.
  • Has a diagnosis of cancer.
  • Has been seen by a prescribing provider within a UCSF Cancer Center-affiliated clinical department within the past 3 months.

Who cannot join

  • Contraindication to any study-related procedure or assessment.
  • No valid contact telephone number.
  • Currently hospitalized or having been discharged from inpatient setting within the past month (according to EHR).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Connect Cancer Patients to Tobacco Cessation Care by Automated Interactive Outreach

This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) delivering cancer-targeted educational messages to support referral to smoking cessation resources for patients with cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate CareConnect's efficacy on referring patients to tobacco cessation resources.

SECONDARY OBJECTIVE:

  1. To evaluate patients' acceptance of referrals.

II. To evaluate the acceptability of CareConnect.

EXPLORATORY OBJECTIVES:

  1. In-depth semi-structured qualitative interviews of 20 selectively chosen participants who completed the 3-month follow-up survey or finished the automated CareConnect or Auto-Reach call but may have refused to complete the 3-month follow-up survey (10 from each group).

II. Smoking cessation with verification. III. To explore factors associated with EHR-documented tobacco cessation treatment or referral at pre-intervention

OUTLINE:

Eligible participants, identified through the Cancer Center Tobacco Registry will be randomized to either the Intervention or Control arm on a 1:1 ratio. Participants who complete the first call of CareConnect or AutoReach will be considered enrolled. Participants will complete a baseline assessment, a 3-month assessment, and have option to provide a saliva sample.

For those who are selected to participate in an in-depth interview, this will take place within 1 month after the 3-month assessment. Data from the participants medical record may be accessed at 6 months post follow-up.

Being tested
CareConnect, AutoReach, Biospecimen samples
Keywords
Interactive Intervention
Medical subject headings
Neoplasms, Tobacco Use Disorder, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CareConnectBehavioural

    Also called Automated Interactive Outreach

    A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)

  • AutoReachOther

    Also called Automated Interactive Outreach

    Phone call / SMS Text

  • Biospecimen samplesProcedure or surgery

    Also called Biological Specimens

    Optional saliva sample

Study groups in NCT05829824
Study groupRoleWhat they receive
CareConnect (Intervention)ExperimentalParticipants will receive automated 'CareConnect' calls/SMS text at enrollment. The call protocol includes up to 2 calls on 2 consecutive days if no response to first call. If there is no response to call, a follow up SMS 3-4 days later. Each CareConnect contact will include (1) assessment, (2) motivational enhancement tailored to participants' tobacco use status and importance of quitting; and (3) multiple referral options (UCSF Fontana Tobacco Treatment Center (FTTC)/tobacco treatment specialist, Quitline, or smoke-freeTXT from smokefree.gov), offered after the motivational enhancement message. CareConnect will notify UCSF tobacco treatment specialist of participants acceptance of any of referral options. Referral options will be documented by specialists on the participants electronic health record (EHR). Participants who have completed the CareConnect call will be contacted by research staff for a 3-month survey to be completed online, by telephone, or postal mail.
Receives: Behavioral: CareConnect; Procedure: Biospecimen samples
AutoReach (Control)OtherParticipants will receive automated AutoReach calls/Short Message Service (SMS) text at enrollment provides one referral option (speaking with a tobacco treatment specialist) and an option for sending information on cessation resources. All participants who have completed the AutoReach call will be contacted by research staff for a 3-month survey to be completed online, by telephone or postal mail.
Receives: Other: AutoReach; Procedure: Biospecimen samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who report using any smoking cessation resources

    Self-reported receipts (recorded as 'yes' or 'no') of evidence-based, smoking cessation services assessed at 3 months post-intervention will be reported as a proportion.

    Measured: Up to 3 months

Secondary outcomes (2)

  1. Proportion of participants who started the call and chose the referrals

    Proportion of participants who started the call and chose the referrals to quitline/speaking with a tobacco treatment specialist or to use smokefree.gov

    Measured: Up to 3 months

  2. Mean Satisfaction Ratings (CareConnect Group Only)

    Participants in the CareConnect intervention group will be asked to respond to the following single item to measure overall satisfaction with the CareConnect intervention from answers to the following question "How helpful was the call you received about tobacco use and cancer care?". The response to this single item is scored on a range from 0= 'Not at all helpful' to 4= 'Extremely helpful'. Higher scores indicate a greater degree of satisfaction.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start27 Nov 2023
  3. Primary completion7 May 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829824
Sponsor's protocol ID
226310
Other IDs
NCI-2023-03215
Status last verified
Oct 2026
First submitted
13 Apr 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CareConnect, AutoReach and Biospecimen samples in people with Cancer and Tobacco Dependence, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who report using any smoking cessation resources (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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